China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3796 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2021-12-31

Brief Summary

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To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year

Group Type EXPERIMENTAL

Tongxinluo

Intervention Type DRUG

tid, po.

Control group

First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

tid, po.

Interventions

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Tongxinluo

tid, po.

Intervention Type DRUG

Placebos

tid, po.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age\>18 years;
2. Within 24 hours of infarctional chest pain onset;
3. ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB);
4. Voluntary participation in the study with consent forms signed.

Exclusion Criteria

1. Critically illness due to STEMI;
2. Long-term (\>20 min) cardio-pulmonary resuscitation (CPR);
3. Suspected aortic dissection or acute pulmonary embolism;
4. Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls.
5. Serious cardiogenic shock and do not responding to hypertensive agents;
6. Uncontrolled acute left heart failure or pulmonary edema;
7. Malignant arrhythmias uncontrolled by anti-arrhythmia agents;
8. Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month;
9. Presence of active hemorrhage at any part of the body (including menstruation);
10. Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders;
11. Current usage of anticoagulants (such as Warfarin or new anticoagulants);
12. . Serious hepatorenal dysfunction \[ATL≥5 ULN (upper limit of normal), Cr\>134μmol/L (2mg%) or eGFR\<45ml/min/1.73m2\];
13. Serious chronic obstructive pulmonary disease (COPD) or respiratory failure;
14. . Severe infection:
15. . Very weak or frailty;
16. . Neuropsychiatric system diseases;
17. . Malignancies;
18. . Other pathophysiological conditions with expected survival time \<1 year;
19. Allergy to the ingredients of this investigational drug;
20. Women who are in pregnancy or nursery;
21. Participation in clinical study of other traditional Chinese medicine (TCM);
22. Unsuitability to participate in this study due to other diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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fuwaihospital

Assistant dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yue-Jin Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING